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Paediatric Clinical Trials in Latvia

Explore the challenges and opportunities in conducting paediatric trials in Latvia, including low enrollment rates, lack of research networks, and feasibility issues. Learn about recent and ongoing trials, data sources, and recommendations for improvement.

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Paediatric Clinical Trials in Latvia

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  1. Paediatric Clinical Trials in Latvia Dina Apele-Freimane, MD PaulsStradins Clinical University Hospital Amanda Smildzere, MD Children Clinical Unversity Hospital

  2. University Hospitals in Latvia Children Clinical University Hospital PaulsStradins Clinical University Hospital Riga East University Hospital Neonates/Infants Adults Only Children Only adults

  3. Paediatric Trials in Latvia • Clinical trial statistics are not encouraging In 2018, only 5 paediatric studies (out of 68 in total) were approved in the State Agency of Medicines of Latvia: - 3 RCT studies for treatment of atopic dermatitis in children > 12 years - 1 RCT influenza treatment in children > 12 years - 1 Phase II PK study in neonates and infants for antibacterial agent • Recently finished and ongoing paediatric trials: - 2 subsequent RCTs for RSV prevention in preterm and term neonates - 1 RCT for influenza vaccine in patients from 6 to 47 months of age • One trial not approved by the National authority - reason for refusal – Paediatric Investigation Plan intended, but not yet submitted to the Paediatric Committee

  4. What makes conduct of paediatric trials problematic? • Small population - high competition for patients - limited enrollment • Feasibility issues (opinion by pharmaceutical companies): - low enrollment - reluctance from healthcare professionals - low parental trust, difficulties to obtain informed consent - lack of general (national) strategy for conducting clinical trials in children

  5. What makes conduct of paediatric trials problematic? • Lack of research networks - we are not “visible” on a global stage -  difficult to keep-up-to-date on the latest research projects • Ethic committees - more than 5 Ethic Committees are functioning in Latvia - the National competent authority does not monitor the activities of the Ethics Committees

  6. Data sources • Hospital data bases • Patient registries – only for specific diagnoses • Follow-up program for preterm neonates: - preterm neonates < 32 weeks of gestational age - dynamic follow-up observation up to 2 years of age • Dynamic follow-up for post-asphyctic neonates with moderated and severe HIE (following to hypothermia treatment) up to 2 years of age Shortcomings: • Lack of a common pediatric patient database – risk of missing data • Longer follow-up for preterm and post-aphyctic neonates would be more informative in terms of neurological and cognitive development

  7. What can be done? Awareness rising • Communication to clinical practitioners - explanation of the importance of paediatric research - training for researchers (practical, communication) • Communication to parents, patient organizations - benefit of paediatric trials - safety of paediatric trials • Joining to global networks, improved international collaboration • Introduction of harmonized diagnostic and endpoint evaluation approaches (e.g. neurodevelopmental assessment for neonates) Improved communication of clinical practitioners to parents → improved obtaining of informed consent → better patient enrollment

  8. Thank you!

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